FDA 510(k)

Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711

Número K: K210565 · 2022-05-05

Data da decisão2022-05-05

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 is the device name listed in this FDA 510(k) record. The listed applicant is Alicn Medical Shenzhen, Inc.. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K210565. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711?

Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Alicn Medical Shenzhen, Inc.. The 510(k) number is K210565.

When did Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 receive FDA 510(k) clearance?

Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 received FDA 510(k) clearance on 2022-05-05, under 510(k) number K210565.

Who is the listed applicant for Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711?

The FDA 510(k) record lists Alicn Medical Shenzhen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711?

The FDA product code for Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 is FLL.

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Outros registros que listam Alicn Medical Shenzhen, Inc. como candidato(a)

K232338Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 K231050Arm Blood Pressure Monitor K230649Arm Blood Pressure Monitor K222248Infrared Thermometer K221913Arm Blood Pressure Monitor K210937Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

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Fonte oficial

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